MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG; VENTRICULAR (ASSIST) BYPASS

Model Number	104232
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the shower bag had been used as usual, but water had penetrated the bag, so it was replaced.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
Additional information stated that the shower bag was closed appropriately.The system controller did not get wet.
Additional Manufacturer Narrative
G2 - report source: corrected.G3 - pma/510(k) #: corrected.Manufacturer's investigation conclusion: evidence of water ingress was confirmed through the evaluation of the returned shower bag.The external portion of the bag did not reveal any damage or wear to any of the seams, zippers, or fabrics that could have contributed to a potential leak.Visual inspection of the interior of the bag revealed light white staining along the upper sides of the bag which appeared consistent with prior water ingress.The bag was mounted in a sink and sprayed directly with water.Following the test, no visible water was observed inside the bag and the interior surfaces did not feel wet to the touch.Although the reported event could not be reproduced during testing, prior water ingress could have contributed to the light white stains.The cause of the water ingress could not be conclusively determined.No alarms were reported.The account communicated that the system controller did not get wet, and no products were damaged.A replacement bag was requested for the patient.The patient remains ongoing on left ventricular assist system support with no further related issues reported at this time.The heartmate 3 lvas ifu, rev.A, and the heartmate 3 patient handbook, rev.C are currently available.The ifu and patient handbook instruct the user to periodically inspect wear and carry accessories for damage or wear.These documents further state, ¿if an accessory appears damaged or worn, do not use it.Contact the manufacturer with questions or to order a replacement, if needed.¿ the ifu and patient handbook also provide instructions on using and assembling the shower bag.The ifu further warns that the shower bag must dry completely between uses.After showering, the exterior of the bag should be wiped with a clean, dry towel, and the bag should be allowed to drip dry completely before being used again.The relevant sections of the device history records for the heartmate gogear shower bag, lot number 8985644, were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21152413
• Report Number: 2916596-2025-00095
• Device Sequence Number: 15725368
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)8985644(11)230414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 104232
• Device Catalogue Number: 104232
• Device Lot Number: 8985644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 02/25/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 53 KG